The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive 3dp Interfixated Alif System.
Device ID | K193593 |
510k Number | K193593 |
Device Name: | NuVasive 3DP Interfixated ALIF System |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Contact | Jessica Leblanc |
Correspondent | Jessica Leblanc NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-23 |
Decision Date | 2020-03-25 |